E-cigarettes: Regulation

Market analysts such as Merrill Lynch and Wells Fargo argue that the regulation of e-cigarettes will be a crucial factor influencing the growth of its market share. At the time of writing, in late January 2014, there is little regulation governing e-cigarettes, either in the UK or anywhere else in the world.
EU Member States preparing new laws take different approaches varying between complete prohibition; regulation as tobacco products,medicinal products and consumer products.[1]

This is set to change if and when revisions to the EU Tobacco Products Directive Revision (the legislation that regulates the manufacture, presentation and sale of tobacco in Europe) are agreed in early 2014. The US Food and Drugs Administration (FDA) is also expected to present its proposals on e-cigarette regulation in 2014.

As regulatory authorities around the world examine whether and how to regulate e-cigarettes, many are predicting that there will be strong opposition to any proposed regulations.

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Bans in Public Places

Due to a lack of regulations concerning e-cigarettes, local authorities and commercial enterprises have started introducing their own rules. In the USA, the number of cities banning the use of e-cigarettes in public places, such as bars, nightclubs and restaurants, and therefore treating them similarly to traditional cigarettes, is growing.

Boston, Chicago, New York and Los Angeles City Council have all voted to ban them. In the UK, different companies have adopted varying positions. The pub chains Wetherspoons and the Slug & Lettuce have banned the use of them insider their establishments, so has the fast food chain McDonald’s. Some train operators, including First Capital Connect, have imposed a complete ban on passengers using the devices.[2]

Meanwhile, Wales could be the first part of the UK to ban smoking e-cigarettes in enclosed public spaces. In early April 2014, the Welsh Health Minister, Professor Mark Drakeford revealed that he was considering a ban amid concerns the products could re-normalise the use of conventional cigarettes. He said there were also concerns that the spread of e-cigarettes could undermine the ban on tobacco smoking in enclosed public spaces, making it more difficult to enforce. The proposal is part of a new set of ideas for public health legislation.[3]

UK Regulation

In the summer of 2013, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK decided that e-cigarettes should be regulated as medicines from 2016. This regulation would require manufacturers to present data on the quality of their products, how they deliver nicotine to the body and how they compare with nicotine-replacement products like patches and gums.[4] However, a final decision will await the outcome of the EU Tobacco Products Directive Revision.

The UK government announced plans to ban sales of e-cigarettes to under-18s. The new regulation could come into force within a year of the announcement in January 2014.[5]

EU Tobacco Products Directive Revision

On 18 December 2013, after years of delay, a political agreement was reached on the text for a revised Tobacco Products Directive (TPD) between the European Commission, Parliament and the Council.[6] This compromise text now has to be approved at a plenary session of the Parliament (expected in February or March 2014) and again by the Council. Once this has occured, Member States will have two years to implement the new rules at national level.
Although the European Commission[7] and the Council[8] proposed to regulate e-cigarettes as a medicine, this approach was rejected by the Parliament in October 2013. In December 2013, a compromise agreement was reached between the three EU institutions which should see e-cigarettes regulated for the first time at EU Level. The compromise agreement provides for two ways of placing e-cigarettes on the market:

as a medicine, if companies choose to make a claim that e-cigarettes help smokers quit smoking

as a consumer product (if companies do not make any health claims) subject to certain safeguards, including:

a limit on nicotine strength of 20mg/ml

quality and purity standards

the same advertising bans as for cigarettes

a size limit and safety mechanisms for e-liquid bottles and refillable cigarettes.

This agreement will also allow the UK Government to introduce extra safeguards for instance on age-limits and flavourings in e-cigarettes.

After the final approvement of the regulation, the Electronic Cigarette Industry Trade Association (ECITA) and other market players vowed to fight the 'unworkable' EU rules.[9]

FDA Regulation in the USA

In April 2014, the American Food and Drug Administration (FDA) published the long-awaited blueprint for regulation on e-cigarettes.[10] The new regulations would ban the sale of e-cigarettes (and cigars and pipe tobacco) to Americans under 18, and would require that people buying them show photo identification to prove their age, measures already mandated in a number of states.

Once finalized, the regulations will establish oversight of what has been a market free-for-all of products, the New York Times wrote, including vials of liquid nicotine of varying quality and unknown provenance:

Under the new rules, companies would no longer be able to offer free samples, and e-cigarettes would have to come with warning labels saying that they contain nicotine, which is addictive. Companies would also not be able to assert that e-cigarettes were less harmful than real cigarettes unless they got approval from the F.D.A. to do so by submitting scientific information.

In the proposed restrictions on sales to minors, vending machines in public places where minors are allowed would no longer be able to carry them. A ban on Internet sales to minors, already in place for cigarettes, would extend to e-cigarettes and cigars.

Companies would have to apply for F.D.A. approval for their products, but would have two years after the new rules are finalized to do so. Companies can keep their products on the market in the meantime.[11]

However,the new blueprint did not contain proposals to ban flavors in e-cigarettes, like bubble gum and grape, that public health experts say lure children to use the products, nor any move to restrict the marketing of e-cigarettes, as is done for traditional cigarettes, which are banned from television, for example.

The new regulatory proposal is open to public comment for 75 days, and then the agency will make final changes, a process that will take months, and possibly significantly longer if affected companies sue to block them.[11]

At present, only e-cigarettes that are marketed for therapeutic purposes are regulated by the FDA Center for Drug Evaluation and Research (CDER) at the national level. Furthermore, 26 US States have banned sales to minors on the basis that smoking e-cigarettes, or vaping, might tempt them to try smoking. [5]

Until new regulation is in place, the position of the FDA is a cautious one. The agency’s website warns that as long as e-cigarettes have not been fully studied, consumers do not know the following:

the potential risks of e-cigarettes when used as intended,

how much nicotine or other potentially harmful chemicals are being inhaled during use, or

if there are any benefits associated with using these products.

Additionally, it is not known if e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which cause disease and lead to premature death.[12]

WHO’s Position on e-Cigarettes

In July 2013, the World Health Organization (WHO) issued a statement on e-cigarettes and advised that consumers should not use e-cigarettes until they are deemed safe. It said the potential risks "remain undetermined" and that the contents of the vapour emissions had not been thoroughly studied.

Contrary to what some marketers of the e-cigarette imply in their advertisements, WHO does not consider it to be a legitimate therapy for smokers trying to quit. Furthermore, the efficacy of e-cigarettes for helping people to quit smoking has not been scientifically demonstrated. According to WHO, they are:

… often touted as tobacco replacements, smoking alternatives or smoking cessation aids. But we know that for smoking cessation products to be most effectively and safely used, they need to be used according to instructions developed for each product through scientific testing.

The WHO concluded it was best to stay away from electronic nicotine delivery systems (ENDS), as they call them:

Until such time as a given ENDS is deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes.[13]